FDA warns Empower Pharmacy over compounding GLP-1 copies in "inordinate amounts"
The Sept. 18 letter is the agency's first intervention in the fight over where personalized compounding ends and mass copying begins.
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By Daniel Okafor · Regulatory Correspondent
Sep 24 11:53 ETSource: CBS News
The wire
- 01The FDA warned Houston-based Empower Pharmacy that it violated federal law by making copies of semaglutide and tirzepatide products in "inordinate amounts"; the letter was posted online Tuesday.
- 02State-licensed pharmacies have kept making altered versions since the FDA declared the shortage over in 2025, citing the carve-out for changes a prescriber says make a significant difference for a patient.
- 03Empower says it has already remediated many issues and will work with the agency; Eli Lilly's separate suit alleging sham personalization remains in litigation.
From the source
Read at cbsnews.comWill an FDA crackdown curb access to cheaper GLP-1 weight-loss drugs? Here's what to know.
The Food and Drug Administration has warned a major compounding pharmacy that it violated federal law by making copies of blockbuster weight-loss drug s in "inordinate amounts."
